Houston Methodist Hospital joins the TriNetX global health research network to provide RWD for study feasibility and academic collaboration in industry-sponsored clinical trials.
Integrated research organizations aim to bridge the gap between clinical research and clinical health care with the use of RWD, yet, the data may not be ready for research, according to Elligo Data Scientist.
A pre-IND review by the US FDA has allowed Virpax to continue with NDAs for DSF100 and LBL100, two pain relief products with specialised drug delivery formulations.
The pharmaceutical and biotech consultancy has opened a new office in Dublin, Ireland ahead of Brexit, the final outcomes of which remain unknown, says CEO.
The EMA needs to fix problems with the clinical trial registry to improve reporting across Europe, says TranspariMED founder, as seemingly small issues can “seriously hinder compliance.”
The introduction of the SPC manufacturing waiver will generate billions in export sales and create a number of jobs across the EU, suggests Medicines for Europe.
Lonza and Emerald Health enter an agreement for the large-scale manufacturing of a synthetic derivative of CBD and its oral drug product for the treatment of MS and other CNS diseases.
Getting patients into possibly life-saving trials has long been a complex process, however, with the age of electronic health records and cloud-based data, there are opportunities for simplification.
Hugh Pullen, EMVO’s president, explains what the launching of the EMVS means for the industry, and details how a potential no-deal Brexit will impact the system.
France, Germany, and the UK recently formed INSTEX to be able to secure trade despite US sanctions on Iran, a move that has been welcomed by Novo Nordisk.
Clinical trial sites often cannot keep up with patient referrals from marketing campaigns – with research suggesting that one-third of referrals are never processed, says patient recruitment firm.
The EMA’s investigation into ‘sartan’ medicines has concluded, requiring companies to review processing procedures and prove products are without impurities.
As 3D printing technology continues to develop, it is becoming more disruptive to the pharmaceutical manufacturing industry as its value in drug delivery becomes apparent, according to IDTechEx.
The approval of the farm bill has intensified interest in CBD but Nexien BioPharma CEO warns pharma-grade products are needed for patients with serious conditions.
The MI-based CRO MMS Holdings is among the team at the Health Analytics Collective, a research group hoping to reduce the need for new clinical trials by using readily available data – and an MIT-incubated programming language.
Purdue announced that it has entered into a partnership deal with Alivio to develop a non-opioid painkiller for the treatment of cystitis and bladder pain syndrome.
The Wasdell Group’s new EU headquarters in Dundalk, Ireland is set to commence operations later this year as part of the company’s “proactive contingency plan” ahead of Brexit.
The UK Parliament is putting pressure on universities failing to publish data from clinical trials – with plans to question institutions later this year following a debrief with AllTrials, which will be monitoring compliance.
Large clinical trials can be particularly useful in the early treatment and prevention of neurodegenerative diseases because of the amount of data collected, though patient recruitment and retention are challenging, says biostatistician.
By Barbara Lopez Kunz, global chief executive, DIA
The practice of incorporating the voice of the patient into clinical development has gained significant traction over the past decade, and rightfully so.
European generics industry faces opposition while pushing for the SPC manufacturing waiver to be altered so it allows for the production of drugs under patent for non-EU countries.
August Research is adding clinical trial operations in Georgia and Moldova, expanding the CRO’s reach in Central and Eastern Europe – a less developed market with “fewer competitive trials and lower costs,” says CEO.
The All of Us research program is expanding its data collection abilities via Fitbit – a move that further demonstrates the industry’s increasing adoption of a BYOD approach, says Thread executive.
Strategikon Pharma releases new modules for its Clinical Maestro software suite – another step in the company’s journey to harmonize sponsor and CRO operations, with further updates slated for later this year, says CCO.
Genetic discoveries have taken place in narrow population groups, say researchers, who for the first time, reveal that such studies are concentrated in a handful of countries – and conducted by a ‘tight-knit group of researchers.’
The industry’s pledge to improving the patient experience drove significant change in 2018 and will continue to do so this year, with so-called “convenience” services to become standard, says Greenphire CCO, who outlines several other trends to watch.
For research in areas such as Parkinson’s disease, digital endpoints may soon be used as primary endpoints, allowing for in-home clinical trials to be conducted over longer periods of time, says CRO.
The two companies will combine technologies to create solid-dose, needle-free vaccines for a number of infectious diseases and emergent threat pathogens.
Awareness around the potential opportunities created by artificial intelligence has never been higher, but pharma’s biggest challenge in 2019 will be adopting and scaling the right technology to improve patient outcomes, says an industry executive.
The more outsourcing experience a pharma company has, the less important its proximity to contract manufacturing partners becomes, outlines Novo Nordisk VP.
By Jim Kremidas, executive director, Association of Clinical Research Professionals
This time next year, I hope I can write a column with the headline “2019: The year of cooperation and communication in the clinical trial industry.” We’ve made some exciting progress toward that end in 2018. Now it’s time to take it to the next level.
The Indian government seeks to boost local drug production by stipulating that the ‘local content’ of domestic products is 75% and 10% for those that are non-domestic.
The biopharma industry is on the precipice of making personalized medicine a reality with access to massive amounts of data, computing power, and artificial intelligence to run in silico clinical trials, says GNS Healthcare CEO.
Clinical trials suggest that long-acting injectable antipsychotics should be expanded into a broader range of clinical settings and patient populations, says Premier Research executive.
Global regulatory agencies had a busy 2018. Here, we take a look back at some of the key developments throughout the year, as the industry navigated challenging politics, pressure to increase transparency, and the rapidly evolving digital health space.
TrialScope this year awarded several companies for their clinical trial data transparency efforts as the industry makes strides to engage patients and the larger health care community.
